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Rosuvastatin 10-40 mg Safe and Well Tolerated Compared to Other Statins: Presented at ISA

By Eurona Earl Tilley

KYOTO, JAPAN -- October 1, 2003 -- When compared to other statins, rosuvastatin is safe and well tolerated at a dose between 10 and 40 mg, a researcher reported here September 30^th at the 13^th International Symposium on Atherosclerosis.

John Pears, MD, AstraZeneca, Alderley Park, Cheshire, United Kingdom, and colleagues assessed the use of rosuvastatin in a clinical trial of 11,210 patients who were part of a larger group participating in core phase II/III trials of rosuvastatin in doses up to 80mg.

Of the participants, 31.3% were elderly, 47.3% were women, 52.5% had renal impairment, 51.8% had hypertension, 36% had cardiovascular disease, and 16.5% had diabetes mellitus. No major differences in demographic characteristics were identified between patients who received rosuvastatin and patients who received other statin agents.

Pooled data on adverse events and laboratory test results from 27 trials were assessed to determine the tolerability and safety of rosuvastatin. The adverse events were reported using Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART).

A review of adverse events demonstrated that the administration of 10 mg to 40 mg doses were as safe as atorvastatin 10 mg to 80 mg, simvastatin 10 mg to 80 mg, pravastatin 10 mg to 40 mg, or placebo.

Minor adverse events associated with the use of rosuvastatin included myalgia in 2.1%, asthenia in 1.2%, nausea in 1.4%, dyspepsia in 0.6%, headache in 1.1%, insomnia in 0.8%, abdominal pain in 1.2%, diarrhoea in 1.1%, constipation in 1.1%, and flatulence in 0.9%.

Myopathy occurred in less than 0.3% of participants, as indicated by an increased creatinine clearance above 10 times the normal upper limit. Elevated alanine, aminotransferase, and aspartate aminotransferase levels were also documented in less than 0.2% of patients. Although proteinura was recorded in approximately 1% of patients who received rosuvastatin 10 mg to 40 mg, it was not associated with acute or progressive renal impairment in any cases.

Dr. Pears asserted that rosuvastatin 10 mg to 40 mg has a favourable safety profile when compared to other statins. Therefore, rosuvastatin should play a considerable role in the management of patients at risk for cardiovascular disease.


[Study title: Safety Profile of Rosuvastatin 10-40 mg in an International Phase II/III Clinical Trial Program. Abstract 2P-0613]

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